SALT LAKE CITY, March 4, 2015 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today announced the Journal of Cutaneous Pathology published data from a pivotal clinical validation study that showed the myPath™ Melanoma test is highly effective at differentiating benign skin moles from malignant melanoma with greater than 90 percent diagnostic accuracy.1 Melanoma is the most dangerous type of skin cancer and more than 76,000 new cases of melanoma are diagnosed each year in the United States.
“Conventional methods of differentiating benign moles from melanoma are effective for many cases, but there is no one-size-fits-all approach. About 15 percent of cases are difficult or impossible to diagnose using standard tools, which can lead to undesirable outcomes such as untreated melanoma, unnecessary treatment or psychological distress,” said Loren Clarke, M.D., medical director for Dermatology at Myriad. “myPath Melanoma is a powerful new molecular diagnostic test that analyzes genetic information inside skin cells to help us understand the biology of a patient’s skin lesion and objectively differentiate benign moles from potentially lethal melanoma.”
The published study describes the discovery, verification and clinical validation of the myPath Melanoma test, which was designed to differentiate benign moles from malignant melanoma. The myPath Melanoma test was developed using a verification cohort of 464 patient samples and was validated in a separate independent study with 437 patient samples from leading academic medical centers in the United States. In both the verification and validation studies, the myPath Melanoma test demonstrated a greater than 90 percent diagnostic accuracy, making it the most accurate molecular diagnostic test developed to date for melanoma. These clinical findings validate the performance, objectivity and reliability of the myPath Melanoma test for clinical use to improve the diagnosis of melanoma.
“The myPath Melanoma study results confirm the test’s potential to more objectively differentiate between benign lesions and malignant melanoma than current evaluation practices,” said Sancy Leachman. M.D., Ph.D., one of the study’s lead investigators and director of the Melanoma Research Program, Knight Cancer Institute, Oregon Health & Science University. “The study results validate the promise of molecular diagnostics in improving the precision of cancer treatment.”
About Myriad myPath Melanoma Testing
Myriad myPath Melanoma is a clinically validated gene expression test designed to differentiate malignant melanoma from benign nevi across all major melanoma subtypes. Myriad myPath Melanoma is a unique test of 23 genes that provides valuable, additive diagnostic information unavailable from any other method – information that can help physicians deliver a more confident diagnosis.
Melanoma is the most serious type of skin cancer. According to the American Cancer Society, about 76,000 new melanomas are diagnosed each year and more than 9,000 people die from the disease annually. Each year in the United States, there are approximately 1.5 million skin biopsies performed specifically for the diagnosis of melanoma, and approximately 15 percent, or 225,000 biopsies, are classified as indeterminate, meaning that the dermatopathologist cannot confidently determine whether the cells are benign or malignant. For more information visit: http://www.isthismelanoma.com and www.myriadpro.com/melanoma.
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic company dedicated to making a difference in patients’ lives through the discovery and commercialization of transformative tests to assess a person’s risk of developing disease, guide treatment decisions, and assess risk of disease progression and recurrence. Myriad is focused on strategic initiatives to grow existing markets, diversify through the introduction of new products, including companion diagnostics, and expand internationally. For more information on how Myriad is making a difference, please visit the Company’s website: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, myRisk Hereditary Cancer, myChoice, myPlan Lung Cancer, BRACAnalysis CDx, HRD, Vectra and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. MYGN-F, MYGN-G
Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the effectiveness of Myriad myPath Melanoma testing to accurately differentiate malignant melanoma from benign lesions and help physicians deliver a more objective and confident diagnosis; the Company’s belief that the Myriad myPath Melanoma test represents a significant advancement in the prompt and accurate diagnosis of potentially fatal melanoma; the clinical use of the Myriad myPath Melanoma test as an adjunct to standard pathology techniques in the evaluation of pigmented skin lesions, particularly in difficult-to-classify cases; the Company’s belief that the Myriad myPath Melanoma test will substantially improve the standard of care for patients with melanoma; and the Company’s strategic initiatives under the caption “About Myriad Genetics.” These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to our ability to transition from our existing single cancer tests to our new cancer panel tests, including unexpected costs and delays; risks related to decisions or changes in the governmental or private insurers reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over our genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services or covering patents or enforcement in the United States and foreign countries generally; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading “Risk Factors” contained in Item 1A of our Annual Report on Form 10-K for the fiscal year ended June 30, 2014, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.
1 Clarke L, Warf M, Flake D, et al: Clinical validation of a gene expression signature that differentiates benign nevi from malignant melanoma. J Cutan Pathol. 2015. Available online at http://onlinelibrary.wiley.com/doi/10.1111/cup.12475/abstract
CONTACT: Media Contact: Ron Rogers (801) 584-3065 rrogers@myriad.com Investor Contact: Scott Gleason (801) 584-1143 sgleason@myriad.com
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